J&J subsidiary recalls one lot of Risperdal, risperidone tablets

TITUSVILLE, N.J. — Johnson & Johnson is recalling 40,000 bottles of a drug used to treat schizophrenia due to consumer reports of the drug having a strange odor, the company said Friday.

J&J subsidiary Ortho-McNeil-Janssen Pharmaceuticals announced the voluntary recall of one lot of Risperdal (risperidone) tablets in the 3-mg strength and a lot of authorized generic risperidone tablets in the 2-mg strength made by Patriot Pharmaceuticals, also a J&J subsidiary.

The recall was started after reports of an “uncharacteristic odor” that is believed to be due to trace amounts of 2,4,6-tribromoanisole, or TBA, a chemical preservative sometimes applied to wood used in the construction of shipping pallets.

The company has recalled several prescription and over-the-counter drug products due to TBA contamination since 2009. Most recently, in May, J&J subsidiary Janssen-Cilag International recalled five lots of the HIV drug Prezista (darunavir) in Canada, the United Kingdom, Ireland, Germany and Austria. In January 2010, J&J instituted actions designed to reduce the potential of TBA contamination, including requiring suppliers to certify that they don’t use pallets made from chemically treated wood.

TBA is not considered toxic, but many people find its odor offensive, and there have been some reports of patients experiencing gastrointestinal problems after taking drugs with the odor.

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